Biomarkers of Muscle Anabolism (MK-0000-082)

January 29, 2015 updated by: Merck Sharp & Dohme LLC

A Randomized, Single-Blind, Placebo-Controlled, Fixed-Sequence, Single-Dose, Parallel Design Study to Utilize Comparative Proteomics to Identify Early Biomarkers of Muscle Anabolism

This study will evaluate the ability of comparative proteomics to identify early biomarkers of muscle anabolism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • subject is a healthy male between 18 and 40 years old
  • subject's weight is stable over the past 3 months
  • subject agrees to refrain from consuming alcohol during study
  • subject agrees to consume no caffeine while in the CRU
  • subject agrees to follow meat-free diet
  • subject is willing to avoid strenuous activity
  • subject has been a nonsmoker for at least 6 months

Exclusion Criteria:

  • subject is a regular user of illicit drugs
  • subject has taken androgenic steroids in the past 12 months
  • subject has participated in sports events, resistance training, or moderate to heavy endurance training in the past month
  • subject has prostate cancer
  • subject has HIV and/or hepatitis B or C

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3
Placebo
Drug: Comparator: placebo
Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 0.8 mL placebo saline solution.
Active Comparator: 1
Low dose testosterone
Drug: Comparator: low dose testosterone
Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 200 mg (0.8 mL) testosterone.
Active Comparator: 2
High dose testosterone
Drug: Comparator: high dose testosterone
Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 600 mg (2.4 mL) testosterone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
comparative proteomics on proteins present in the vastus lateralis or plasma
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
mRNA or miRNA expression in the vastus lateralis or in peripheral blood
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

December 19, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (Estimate)

December 22, 2008

Study Record Updates

Last Update Posted (Estimate)

January 30, 2015

Last Update Submitted That Met QC Criteria

January 29, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000-082
  • 2008_602

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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